NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorWest Virginia University
About this trial
This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk screening, suicide risk assessment, safety planning, referral procedures, and follow-up care activities for adolescents receiving health services.
The study will assess implementation outcomes, including suicide screening practices, identification of suicide risk, safety planning, and follow-up service delivery, as well as participant outcomes including suicidal ideation, depressive symptoms, satisfaction with services, suicidal behavior, safety plan utilization, and acute care utilization. Data collected across participating sites will be combined to evaluate the feasibility, acceptability, and preliminary effectiveness of the adapted Clinical Pathway. Protocol amendments resulted in consolidation of site-specific outcome measures into combined analyses across participating school-based health centers. The ClinicalTrials.gov record was updated to reflect the current protocol, study procedures, and planned statistical analyses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Youth who are receiving services at the school-based health centers to participate
Parents must be able to give legal consent for themselves and their children to participate
Youth and Parent must be English-speaking
Youth must also be able to give signed assent to participate
Disqualifiers
Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.
Trial design
Design model
Single group
Treatments tested in this trial
NIMH Clinical Pathway
BehavioralComplete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Treatment As Usual (TAU)No intervention 0 interventions
Group B: NIMH Clinical PathwayActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Patients Screened for Suicidal Risk
Percentage of patients to determine how many received documented screening for suicide risk during their visit. Data will be combined across both study sites. The outcome will be calculated as the number of patients screened for suicide risk divided by the total number of eligible patients receiving services during the review. Review will occur for 9 months during the baseline and intervention phases.
Time frame
9 Months2
Percentage of Patients with a Positive Screen for Suicide Risk
Percentage of patients were identified as a positive screen for suicide risk. Data will be combined across both study sites. The outcome will be calculated as the number of patients with a positive suicide risk screen divided by the total number of patients screened during the review period. Review will occur for 9 months, which will include the baseline and intervention phases.
Time frame
9 MonthsSecondary outcomes
1
Rate of Patients Receiving Safety Planning
Percentage of screen-positive patients who received a safety plan intervention during the baseline visit. The baseline visit is defined as the clinic visit during which a participant screens positive for suicide risk and is identified for study follow-up procedures.
Time frame
Baseline Visit2
Follow-Up Service Provision Rate
Percentage of screen-positive patients who were seen by a provider at the school clinic within 3 months of baseline visit.
Time frame
Up to 3 Months Post Baseline Visit3
Suicidal Ideation Questionnaire (SIQ-Jr)
Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants two times within 3 months of the baseline visit. The SIQ-Jr is a 15-item self-report questionnaire that measures suicidal thoughts on a 7-point scale ("0- I never had this thought" to "6- I have this thought every day"). Scores range from 0-90, SIQ-Jr scores of 30 and above indicate severe suicidal ideation and the need for clinical intervention.
Time frame
Up to 3 Months Post Baseline Visit4
Center for Epidemiological Studies Depression Scale (CES-D)
The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to participants two times within 3 months of the baseline visit. The CES-D is a self-report measure with 10 items asking about the frequency with which individuals have experienced various symptoms of depression within the last week. Each item is rated on a Likert scale, typically ranging from 0 (rarely or none of the time) to 3 (most or all of the time). Total scores range is from 0-30, with higher scores indicating higher levels of depression.
Time frame
Up to 3 Months Post Baseline VisitSponsors and contacts
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West Virginia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov